COMMENTARY Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Cimetidine

Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release (IR) solid oral dosage forms containing cimetidine are reviewed. According to the current Biopharmaceutics Classification System (BCS), cimetidine would be assigned to Class III. Cimetidine’s therapeutic use and therapeutic index, its pharmacokinetic properties, data related to the possibility of excipient interactions, and reported BE/bioavailability (BA) problems werealso taken into consideration.Onthebasis of the overall evidence, abiowaiver canbe recommended for cimetidine IR products, provided that the test product contains only those excipients reported in this paper in their usual amounts, and that the test and the comparator drug products both are ‘‘rapidly dissolving’’ as per BCS. 2006Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 95:974–984, 2006